Clinical trial · Interventional
A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis by Detecting CTCs
A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis Detecting Circulating Tumor Cells
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Docetaxel plus carboplatin and trastuzumab has been a standard treatment for patients with human epidermal growth factor receptor-2（HER-2）positive. The investigators witnessed a higher pathological complete remission(pCR) rate but no obvious increase in cardiac toxicity when used the anthracycline instead of carboplatin. The investigators expect to carry out a large sample size clinical research to optimize the existing therapeutic regimen
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A group
- description
- docetaxel+carboplatin+trastuzumab
- interventionNames
- Drug: Docetaxel
- Drug: Trastuzumab
- Drug: Carboplatin
- type
- ACTIVE_COMPARATOR
- label
- B group
- description
- Epirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab
- interventionNames
- Drug: Epirubicin
- Drug: Docetaxel
- Drug: Trastuzumab
Primary outcomes (1)
- measure
- pathological complete response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * 18≤aged\<70 * pathologic diagnosis of invasive breast cancer，staging ii to iii，the diameters≥2cm indicated by MRI or axillary lymph node（+） * Immunohistochemical（IHC） positive for 3+ or FISH（+） * clear hormone receptor（HR） status * Eastern cooperative oncology group(ECOG)=0/1 * LVEF≥55% * pathologic grading of Miller and Payne * screening laboratory values with the following parameters：absolute neutrophils acount：≥1500/mm3,total bilirubin:≤2.0×ULM,Aspartate transaminase (AST)/ALT≤2.5×ULM,platelet≥80000/mm3，serum creatinine≤1.5×ULM * no pregnant or nursing * signed Informed consent forms Exclusion Criteria: * prior exposure to any treatments for breast cancer * inflammatory/Bilateral/IV stage breast cancer * poor physical condition * pregnant or nursing * Cardiac risk（Congestive heart failure、arrhythmia、myocardial infarct、Refractory hypertension（systolic pressure\>180mmHg/diastolic pressure\>100mmHg）） * any other cancer within 5 years prior to screening with the exception of cervical carcinoma and non melanoma skin cancer * Allergic to chemotherapy drugs
References
Publications (0)
Data not yet available